510(k) K980165

INFUTEST 2000 INFUSION DEVICE ANALYZER by Datrend Systems, Inc. — Product Code MRZ

K980165 is an FDA 510(k) premarket notification submitted by Datrend Systems, Inc. for the device "INFUTEST 2000 INFUSION DEVICE ANALYZER". The FDA issued a decision of Substantially Equivalent on April 20, 1998. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Datrend Systems, Inc. has at least 1 other 510(k) clearance on record.